A Safety and Effectiveness Study of Intraspinal MDT2004 for the Treatment of Chronic Pain

This study has been terminated.

(Study closed and subject follow-up completed following analysis of blinded study data.)

Sponsor:

Information provided by:

MedtronicNeuro

ClinicalTrials.gov Identifier:

NCT00414466

First received: December 20, 2006

Last updated: May 6, 2011

Last verified: May 2011

Results First Received: December 22, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Chronic Intractable Pain
Intervention:	Drug: Intraspinal MDT2004

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 254 subjects were enrolled into the study between December 2006 and October 2009.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
During a 2-week screening period subjects were required to meet eligibility criteria including maintaing stable pain medications and demonstrating a numerical pain rating score of 6 or greater averaged over the last 7 days of screening. A total of 170 subjects met eligibility criteria, were implanted with an infusion system and were randomized.

Reporting Groups

	Description
1 Placebo	Intraspinal Placebo delivered continuously for 29 days via an implantable infusion system
2 MDT2004 Low	Intraspinal MDT2004 Low delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
3 MDT2004 Medium	Intraspinal MDT2004 Medium delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
4 MDT2004 High	Intraspinal MDT2004 High delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose

Participant Flow: Overall Study

	1 Placebo	2 MDT2004 Low	3 MDT2004 Medium	4 MDT2004 High
STARTED	44	42	41	43
COMPLETED	42	42	40	42
NOT COMPLETED	2	0	1	1
Adverse Event	0	0	1	1
Lack of Efficacy	1	0	0	0
Withdrawn by Sponsor	1	0	0	0

Baseline Characteristics

Reporting Groups

	Description
1 Placebo	Intraspinal Placebo delivered continuously for 29 days via an implantable infusion system
2 MDT2004 Low	Intraspinal MDT2004 Low delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
3 MDT2004 Medium	Intraspinal MDT2004 Medium delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
4 MDT2004 High	Intraspinal MDT2004 High delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
Total	Total of all reporting groups

Baseline Measures

	1 Placebo	2 MDT2004 Low	3 MDT2004 Medium	4 MDT2004 High	Total
Number of Participants [units: participants]	44	42	41	43	170
Age [units: participants]
<=18 years	0	0	0	0	0
Between 18 and 65 years	39	41	40	40	160
>=65 years	5	1	1	3	10
Age [units: years] Mean ± Standard Deviation	51.8 ± 11.2	50.1 ± 9.9	48.1 ± 9.4	48.3 ± 11.1	49.6 ± 10.5
Gender [units: participants]
Female	27	28	20	23	98
Male	17	14	21	20	72
Region of Enrollment [units: participants]
United States	44	42	41	43	170